Suture Removal Kit
FDA 510(k) K855131 · Dynarex Corp.
510(k) numberK855131
Submission
- Device name
- Suture Removal Kit
- Applicant
- Dynarex Corp.
Brewster, NY, US - Received
- December 23, 1985
- Decision date
- January 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOK – Scissors, Medical, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6820
- Specialty
- General Hospital
Other 510(k)s with product code JOK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843075 | Utility Scissors Disposable ItemsJOK · Traditional | Greene International Corp. | 09/05/1984SE |
| K812555 | Disposable Suture Removal ScissorsJOK · Traditional | Medcare Products | 11/16/1981SE |
| K770595 | Suture Removal SetJOK · Traditional | Abco Dealers, Inc. | 05/23/1977SE |
| K770481 | Shear, Plastic Handle Utility S-475-7JOK · Traditional | Acme United Corp. | 04/29/1977SE |
| K770163 | Suture CutterJOK · Traditional | Concept, Inc. | 03/30/1977SE |
| K761192 | Dressing Change KitJOK · Traditional | Superior Plastic Products Corp. | 02/28/1977SE |
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Questions and answers
When was Suture Removal Kit cleared by the FDA?
Suture Removal Kit (K855131) received a 510(k) decision of Substantially Equivalent on January 13, 1986, 21 days after the submission was received.
What is the product code of K855131?
The FDA product code is JOK – Scissors, Medical, Disposable, a Class I (low risk) device regulated under 21 CFR 880.6820.